Director of Regulatory Affairs

Also called: Head of Regulatory Strategy

Plans the strategy to get new medicines approved and negotiates with the FDA.

A day in the life

Leads a meeting with FDA officials about what a trial needs to show, then advises executives on whether to pursue fast-track approval.

Pay over a career

Starting
$140k
Typical
$195k
High
$270k

Industry estimate.

Approximate: anchored on Bureau of Labor Statistics data for a broader job group.

Training

Master's degree, about 12 years after high school. Master's, PhD, or PharmD plus 10+ years of experience.

Ways in: 4-year college, Graduate school, On-the-job training. Training cost: $60k – $150k.

Majors to look at: Regulatory Science, Biology, Pharmacy.

Outlook

Growing faster than average (about 5% over 10 years). Estimate.

Will it last? Our AI estimate

Low risk in 5 years, medium in 10. AI drafts documents and searches past FDA rulings; negotiating with regulators and advising executives stay human.

Start now, in high school

Classes: AP Government, AP Biology, Speech or debate.

Official data: O*NET occupation 11-9199.

More Biomanufacturing, Quality & Regulatory careers

Career Universe is an early version. Pay, training and AI-risk figures are estimates to start your own research, not verified facts. The research was written with AI research assistants, checked by validation scripts and spot-checked by hand. Check anything important with schools, employers and official sources. How the numbers work.